Long-term, High Blood Flow Hemoadsorption Therapy in Patients Undergoing Maintenance Hemodialysis

Phase 4

• Conditions: Chronic Kidney Diseases; Hemodialysis
• Interventions: Other: long-term, high blood flow hemoadsorption therapy

• Registration Number: NCT06574425
• Lead Sponsor: Dongliang Zhang, MD

Brief Summary

Objective：The purpose of the study is to confirm that extending the duration of hemoadsorption (HA) and increasing blood flow during the HA+hemodialysis (HD) treatment process is safe and feasible, and to verify that extending the HP treatment duration can further increase the clearance of protein-bound uremic toxins.

Methods: The study employs a multicenter, prospective, cohort design with a self-controlled before-and-after comparison. The duration of HA+HD treatment for maintenance hemodialysis (MHD) patients is extended to 4 hours, and the extracorporeal blood flow rate is increased to over 250-350 ml/min. The safety of the treatment is assessed by evaluating the safety of the procedure; the levels of relevant toxins in the patients' blood are measured before and after treatment, and the clearance rate of uremic toxins after a single treatment is calculated and compared with the self-controlled before-and-after data to determine whether the modified protocol can remove more uremic toxins.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-25
• Study First Submitted QC: 2024-08-25
• Study Start: 2024-08-28
• Study First Posted: 2024-08-28
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-14
• Last Update Posted: 2024-12-18
• Primary Completion: 2025-05-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Maintenance Hemodialysis Patients with Uremia receive regular HA+HD treatment

Exclusion Criteria

Plasma albumin <30g/L, severe malnutrition or cachectic state; platelet count <40×10^9/L or >300×10^9/L; hypercoagulable state allergy to the hemoperfusion device; new cardiovascular or cerebrovascular diseases; poor vascular access function, extracorporeal circulation blood flow unable to reach 250ml/min ultrafiltration volume >4500ml in a single dialysis session use of non-heparin anticoagulants inability to comply with the procedures of this study other conditions deemed unsuitable for participation in this study by the investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients undergoing maintenance hemodialysis with once-weekly hemoadsorption	long-term, high blood flow hemoadsorption therapy	The blood flow rate is based on the actual blood flow speed displayed by the dialysis machine; the dialysis fluid flow rate is 500 ml/min; the total ultrafiltration volume in 4 hours does not exceed 4500 ml.All subjects undergo a self-controlled before-and-after comparison, with continuous 3 weeks of HA+HD treatment, once a week. The HA+HD treatment is implemented at a short interval of 1 day after the previous dialysis treatment. Group 1 is the routine treatment group, Group 2 is the extended time group, and Group 3 is the extended time and increased blood flow group, also known as the modified HA+HD group. The treatment modes of the three groups are implemented sequentially in order.

Primary Outcome Measures

Name	Time	Method
protein-bound toxins	1month	the clearance of protein-bound toxins will change

Trial Locations

Locations (1)

Nephrology Department of Beijing Jishuitan Hospital; 🇨🇳 Beijing, Beijing, China